Evaluation of the Kaira COVID-19/Flu/RSV Detection Kit for detection of SARS-CoV-2, influenza A/B, and respiratory syncytial virus: A comparative study with the PowerChek SARS-CoV-2, influenza A&B, RSV Multiplex Real-time PCR Kit

PLoS One. 2022 Dec 14;17(12):e0278530. doi: 10.1371/journal.pone.0278530. eCollection 2022.

Abstract

Background: Co-circulation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and other respiratory viruses, such as influenza and respiratory syncytial virus (RSV), can be a severe threat to public health. The accurate detection and differentiation of these viruses are essential for clinical laboratories. Herein, we comparatively evaluated the performance of the Kaira COVID-19/Flu/RSV Detection Kit (Kaira; Optolane, Seongnam, Korea) for detection of SARS-CoV-2, influenza A and B, and RSV in nasopharyngeal swab (NPS) specimens with that of the PowerChek SARS-CoV-2, Influenza A&B, RSV Multiplex Real-time PCR Kit (PowerChek; Kogene Biotech, Seoul, Korea).

Methods: A total of 250 archived NPS specimens collected for routine clinical testing were tested in parallel by the Kaira and PowerChek assays. RNA standards were serially diluted and tested by the Kaira assay to calculate the limit of detection (LOD).

Results: The positive and negative percent agreements between the Kaira and PowerChek assays were as follows: 100% (49/49) and 100% (201/201) for SARS-CoV-2; 100% (50/50) and 99.0% (198/200) for influenza A; 100% (50/50) and 100% (200/200) for influenza B; and 100% (51/51) and 100% (199/199) for RSV, respectively. The LODs of the Kaira assay for SARS-CoV-2, influenza A and B, and RSV were 106.1, 717.1, 287.3, and 442.9 copies/mL, respectively.

Conclusions: The Kaira assay showed comparable performance to the PowerChek assay for detection of SARS-CoV-2, influenza A and B, and RSV in NPS specimens, indicating that the Kaira assay could be a useful diagnostic tool when these viruses are co-circulating.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Animals
  • COVID-19* / diagnosis
  • Humans
  • Influenza B virus / genetics
  • Influenza, Human* / diagnosis
  • Nasopharynx
  • Real-Time Polymerase Chain Reaction
  • Respiratory Syncytial Virus Infections*
  • Respiratory Syncytial Virus, Human* / genetics
  • SARS-CoV-2 / genetics
  • Sensitivity and Specificity
  • Spiders* / genetics

Grants and funding

This work was supported by the Korea Medical Device Development Fund grant (https://www.kmdf.org/) funded by the Korea government (the Ministry of Science and ICT, the Ministry of Trade, Industry, and Energy, the Ministry of Health & Welfare, and the Ministry of Food and Drug Safety) (project number: 202011A04; PI: HJH) and a grant of the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI; https://www.khidi.or.kr/), funded by the Ministry of Health & Welfare, Republic of Korea (grant number: HW20C2130; PI: HJH). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.